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[Laboratory and clinical studies on cefprozil in the field of pediatrics]
1Department of Pediatrics, Anjo Kosei Hospital.
Insights
Cefprozil (CFPZ), a new oral antibiotic, demonstrated favorable pharmacokinetics and potent antibacterial activity against common pediatric pathogens. Clinical trials showed high efficacy in treating acute infectious diseases with minimal side effects.
Area of Science:
- Pediatric infectious diseases
- Pharmacology and pharmacokinetics
- Antimicrobial chemotherapy
Background:
- Cefprozil (CFPZ) is a novel cephem antibiotic.
- Pediatric applications of antibiotics require specific pharmacokinetic and efficacy data.
Purpose of the Study:
- To evaluate the pharmacokinetics, in vitro antibacterial activity, and clinical efficacy of cefprozil in pediatric patients.
- To compare cefprozil's activity with existing antibiotics like cefaclor and ampicillin.
Main Methods:
- Pharmacokinetic analysis of serum and urine concentrations after oral administration of cefprozil in pediatric subjects.
- In vitro determination of minimum inhibitory concentrations (MICs) against various clinical isolates.
- Clinical efficacy assessment in pediatric patients with acute infectious diseases.
Main Results:
- Cefprozil exhibited favorable serum pharmacokinetics with peak levels at 1-2 hours and half-lives of 0.69-0.95 hours.
- In vitro, cefprozil showed superior activity against Gram-positive cocci compared to cefaclor and against E. coli compared to ampicillin.
- Clinical studies reported a 100% clinical efficacy rate and 56% bacteriological efficacy rate for cefprozil in treating pediatric infections.
Conclusions:
- Cefprozil demonstrates promising pharmacokinetic properties and potent in vitro antibacterial activity relevant for pediatric use.
- The antibiotic achieved high clinical efficacy in treating various acute pediatric infections with a favorable safety profile.
- Cefprozil represents a valuable therapeutic option for pediatric infectious diseases.
Abstract:
Laboratory and clinical studies on cefprozil (CFPZ, BMY-28100), a new cephem antibiotic, were carried out in the field of pediatrics. The results obtained are summarized as follows: 1. Serum concentrations, urinary concentrations and urinary recovery rates of CFPZ were determined upon oral administration of CFPZ after meal at doses of 4 mg/kg granules in a case, 7.5 mg/kg granules in 2 cases and 15 mg/kg granules in one. Peak serum levels of CFPZ were obtained at an hour in 3 cases and at 2 hours in 1 case after administration of the drug with a range of 2.7-8.6 micrograms/ml with half-lives of 0.69-0.95 hours. Urinary recovery rates in the first 6 hours after administration ranged from 59.4-71.3%. 2. MICs of CFPZ against 36 clinical isolates (Staphylococcus aureus 4 strains, Streptococcus pneumoniae 5, Streptococcus pyogenes 5, Escherichia coli 5, Haemophilus influenzae 12, Haemophilus parainfluenzae 4, and Branhamella catarrhalis 1) were compared with those of cefaclor (CCL) and ampicillin (ABPC). The antibacterial activity of CFPZ was superior to those of CCL against Gram-positive cocci, and to those of ABPC against E. coli, and was equal to those of CCL and inferior to those of ABPC against H. influenzae. 3. Thirty-seven pediatric patients with acute infectious diseases (pharyngitis/tonsillitis 17, bronchitis 7, pneumonia 3, skin and soft tissue infection 2, and urinary tract infection 8) were treated with CFPZ at daily doses of 10-47 mg/kg t.i.d. as a rule. The efficacy rates were 100% clinically and 56% bacteriologically. 4. Side effects or abnormal laboratory test values were not observed except for an increased platelet count in 1 case and elevated GOT, GPT values in 2 cases.